External Marker Cover A

External Marker Cover A - MAJ-997

A multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three-dimensional (3-D) virtual images on a monitoring screen. The system primarily consists of a main control unit with monitor and an external EM field generator or sensor, and may also require/include an external reference sensor; additional accessories (e.g., remote control, stand/trolley) may also be included.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGU

Device Name: Spatial Imaging For Display Of Endoscope Position

Device Class: 2

Physical State: A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.

Definition: To detect and display the shape of an inserted endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Gastrointestinal system

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: FDF

Device Name: Colonoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with colonoscope

Definition: To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted into anus

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: colon or rectum

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170077760

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A